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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CONTEC - 06945040101406

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC6000
In Commercial Distribution

  • 06945040101406 ()


  • Electrocardiographic ambulatory recorder

CONTEC - 06945040100294

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5000
In Commercial Distribution

  • 06945040100294 ()


  • Electrocardiographic ambulatory recorder

CONTEC - 06945040101499

Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5007
In Commercial Distribution

  • 06945040101499 ()


  • Electrocardiographic ambulatory recorder

ORLocate - 00724995243692

Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Tablet
In Commercial Distribution

OX216

  • Electronic surgical sponge-counter

Welch Allyn, Inc. - 00732094334944

RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; AM12 Wired Acquisition Module; Adult and pediatric interpretation; Software kit; US/Canada power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; Standard connectivity-includes XML order and XML/PDF output (required for HL7 interfacing)
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094334944 ()
RSCRIBE-6CC-AXDBA

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328851

H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328851 ()
H12PLUS-LPC-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094327779

H12+ High Fidelity 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); AHA 10 wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends;
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094327779 ()
H12PLUS-NPA-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328868

H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328868 ()
H12PLUS-LPB-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328844

H12+ Standard 12-lead digital Holter Recorder - 24-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12-lead LeadForm 63" (160cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328844 ()
H12PLUS-LPD-XXXXX

  • Electrocardiographic ambulatory recorder

Welch Allyn, Inc. - 00732094328837

H12+ Standard 12-lead digital Holter Recorder - 48-hour, includes secure digital (SD) card, carry case, and hookup kit; Multiple languages and CD manual (except Brazilian Portuguese); IEC 10-wire, 12-lead LeadForm 38" (97cm) patient cable with snap ends
WELCH ALLYN, INC.
901141
In Commercial Distribution

  • 00732094328837 ()
H12PLUS-MPB-XXXXX

  • Electrocardiographic ambulatory recorder
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